i

IMAGING FINDINGS IN INFERTILE FEMALE PATIENTS WHO

UNDERWENT HYSTEROSALPINGOGRAPHY INVESTIGATION

AT MUHIMBILI NATIONAL HOSPITAL

Ramadhan Bihindi Kabala,MD

MMED (Radiology) Dissertation

Muhimbili University of Health and Allied Sciences

April 2011

ii

IMAGING FINDINGS IN INFERTILE FEMALE PATIENTS WHO

UNDERWENT HYSTEROSALPINGOGRAPHY INVESTIGATION AT MUHIMBILI NATIONAL HOSPITAL

By

Ramadhan Bihindi Kabala,MD

A dissertation/Thesis Submitted in Partial Fulfilment of the Requirements for the Degree of Master of Medicine (Radiology) of

Muhimbili University of Health and Allied Sciences

Muhimbili University of Health and Allied Sciences April 2011

iii

CERTIFICATION

The undersigned certify that he has read and hereby recommend for examination the dissertation entitled “Imaging findings in infertile female patients who underwent hysterosalpingography investigation at Muhimbili National hospital” in fulfilment of the requirements for the degree of Master of Medicine (Radiology) of

Muhimbili University of Health and Allied Sciences.

_______________________________ Dr Kazema RR

(Supervisor)

Date: ___________________________

iv

DECRALATION AND COPYRIGHT

I, Ramadhan B Kabala, declare that this dissertation entitled “Imaging findings in infertile

female patients who underwent hysterosalpingography investigation at Muhimbili

National hospital ” is my own original work and that it has not been presented and will not

be presented to any other university for a similar or any other degree award.

Signature………………………………………. Date………………..

This dissertation is a copyright material protected under the Berne Convention, the Copyright

Act 1999 and other international and national enactments, in that behalf, on intellectual

property. It may not be reproduced by any means, in full or in part, except for short extracts in

fair dealing, for research or private study, critical scholarly review or discourse with an

acknowledgement, without the written permission of the Directorate of Postgraduate Studies,

on behalf of both the author and the Muhimbili University of Health and Allied Sciences.

v

ABSTRACT

Background

Fallopian tube and uterine defects are responsible for infertility in more than 30% of infertile

couples. Hysterosalpingography (HSG) is a safe and less invasive method of detecting both

the tubal and uterine defects.

Objectives

To describe hysterosalpingography (HSG) imaging findings in infertile female patients

investigated at Muhimbili National Hospital (MNH)/Radiology department from July to

December,2010

Material and methods

This descriptive cross-sectional study, involved 130 women participants with infertility who

attended MNH Radiology department for HSG examination between July to December 2010.

Demographic data and radiological findings were reviewed and the obtained data analysed

with SPSS version 15. Statistical level of significance was set at p < 0.05.

Results

The participants mean age was 30 years and mean duration for infertility was 5 years.

Secondary infertility was slightly commoner than primary infertility. Majority (70%) of

patients were aged 16-30 years. Abnormal findings at HSG were found in 60% of the patients.

Most of these abnormal findings were found in those patients with older age between 31 and

45 years and those with long duration of infertility for more than 5 years. The commonest

finding was tubal blockage accounting 41% of cases and the least was uterine congenital

abnormality (3.8%). Uterine fibroid was the commonest uterine pathology accounting for

10% of all cases.

Conclusion

Generally, high proportion of patients in this study showed presence of uterine and fallopian

tubes pathology. Fallopian tubal blockage was the most diagnosed tubal structural

abnormality while the uterine leiomyoma was the highest uterine pathology. There was no

vi

significant difference in the presence of pathology between patients with primary and

secondary infertility. However, older age above 30 years were significantly associated with

presence of structural abnormality in both uterus and fallopian tubes

Recommendation

HSG is recommended for initial routine work-up of infertile women.

Further studies are needed to establish the aetiologies of these abnormalities.

.

vii

TABLE OF CONTENTS CERTIFICATION .....................................................................................................................iii DECRALATION AND COPYRIGHT...................................................................................... iv ABSTRACT................................................................................................................................ v ACRONYMS............................................................................................................................. ix LIST OF TABLES ...................................................................................................................... x LIST OF FIGURES ................................................................................................................... xi DEDICATION ..........................................................................................................................xii ACKNOWLEDGEMENTS.....................................................................................................xiii 1.0 INTRODUCTION AND LITERATURE REVIEW............................................................ 1

1.1 Prevalence of infertility..................................................................................................... 1 1.2 Radiological investigations of infertility........................................................................... 2 1.3 HSG Findings.................................................................................................................... 4

2.0 PROBLEM STATEMENT ................................................................................................... 7 3.0 STUDY RATIONALE.......................................................................................................... 8 4.0 OBJECTIVES ..................................................................................................................... 10

4.1 Broad Objectives............................................................................................................. 10 4.2 Specific Objectives......................................................................................................... 10

5.0 METHODOLOGY.............................................................................................................. 11 5.1 Study design and period ............................................................................................. 11 5.2 Study setting ............................................................................................................... 12 5.3 Study population......................................................................................................... 12 5.4 Exclusion criteria........................................................................................................ 12 5.5 Sample size Estimation .............................................................................................. 12 5.6 Sampling technique .................................................................................................... 12 5.7 Data collection............................................................................................................ 12

5.8 Data analysis..............................................................................................................13 5.9 Ethical consideration.................................................................................................. 13

6.0 RESULTS ........................................................................................................................... 14 6.1 Demographic and clinical data........................................................................................ 14 6.2 Hysterosalpingography findings ..................................................................................... 15

6.2.1 HSG findings by demographic characteristicts and fertility status.......................... 15 6.2.2 Pattern of uterine and fallopian tubes abnormalities................................................ 17 6.2.3 HSG uterine findings ............................................................................................. 187 6.2.4 HSG fallopian tubes findings................................................................................... 18

7.0 DISCUSSION .................................................................................................................... 21 8.0 STUDY LIMITATION....................................................................................................... 27 9.0 CONCLUSION................................................................................................................... 27 10.0 RECOMMENDATIONS.................................................................................................. 28 11.0 REFERENCES.................................................................................................................. 29 APPENDEX:I. DATA COLLECTION SHEET....................................................................... 34

viii

APPENDEX: II. Consent: English version............................................................................... 36 APPENDEX: III. Consent: Swahili version.............................................................................. 38

ix

ACRONYMS

CI; Confidence interval

HSG; Hysterosalpingography

IRB; Institutional Review Board

LMP; Last Menstrual period

MNH; Muhimbili National Hospital

MRI; Magnetic Resonance Imaging

MUHAS; Muhimbili University Of Health and Allied Sciences

PID; Pelvic inflammatory disease

S.d; Standard deviation

SPSS; Statistical Package for Social Science

UK; United kingdom

x

LIST OF TABLES Page

Table 1: Descriptive statistics ...............................................................................................12

Table 2: Age distribution by type of infertility......................................................................13

Table 3: HSG findings by demographic characteristics and fertility status...........................14

Table 4: Summary of HSG uterine findings...........................................................................15

Table 5: Summary of HSG fallopian tubes findings..............................................................16

xi

LIST OF FIGURES Page

Figure 1: Histogram showing age distribution of patients...............................................12

Figure 2: Distribution of uterotubal abnormalities..........................................................14

Figure 3: HSG images showing bicornuate uterus..........................................................15

Figure 4: HSG images showing a filling defect due to fibroid........................................16

Figure 5: HSG image showing hydrosalpinx..................................................................17

Figure 6: Normal HSG images.......................................................................................18

xii

DEDICATION I dedicate this dissertation to my mother, Asha Ramadhan, my wife Rahma Lugoye Antony and our children Hashim and Aisha.

xiii

ACKNOW LEDGEMENTS

My sincere gratitude and appreciation to the Ministry of Health and Social Welfare for

sponsoring my course and this dissertation. I’m greatly indebted to my supervisor Dr. Kazema

R R for his valuable advice and support throughout the study period. His tireless efforts,

encouragement and constructive inputs made this work a success. Sincere appreciations to the

Head of Muhimbili National Hospital Radiology Department and members of the department

for their tireless assistance and advice during the period of preparation of this dissertation.

Special thanks to Dr.Hokororo J, Dr. Akoko L and Dr. Mwanga A for their support during

data analysis. I am also indebted to my family and friends for their tireless moral and material

support.

1

1.0 INTRODUCTION AND LITERATURE REVIEW

1.1 Prevalence of infertility

The problem of infertility in our setting is common in day to day practice. Infertility is

defined as the inability of a couple to achieve conception after 12 months doing

unprotected coitus. Primary infertility describes couples who have never been able to

become pregnant after at least 1 year of unprotected sexual intercourse. Secondary

infertility describes couples who have been pregnant at least once, but have not been able

to become pregnant again. It is estimated that 8 to 15% of all women experience primary

or secondary infertility at one point in time in their reproductive life. In tropical Africa,

infertility rate is between 10% to 20%, although the prevalence in Congo was reported to

be high between 30% to 50% (1, 2, 3, 4). In Tanzania national demographic and health

survey conducted in 1999 showed that 2.5% of women had primary infertility while 18%

had secondary infertility. The prevalence of infertility was 8.1% in previous study

conducted in Moshi northern part of Tanzania with secondary infertility being more

common than primary infertility (5).

Primary infertility is relatively low and it exceeds 3% in most African countries (5).

Several studies showed that secondary infertility is more common than primary infertility

(6, 7, 8). Secondary infertility for women aged 20-44 ranges from 5% in Togo to 23% in

Central Africa Republic (5). Some studies done in Turkey and Iran found out that

primary infertility was more common, when compared to secondary infertility (9,10).

Women with secondary infertility have a higher likelihood of having structural

abnormalities in both uterus and fallopian tubes in comparison to those with primary

infertility (11,12).

2

1.2 Radiological investigations of infertility

Hysterosalpingography (HSG) is readily available investigation in our settings, as such

is one among the investigations used for evaluation of infertility. It is the best first line

anatomic imaging investigation for the basic infertility work. HSG evaluates the cervical

canal, uterus, fallopian tubes and the pelvic cavity (13,14).

Hysterosalpingography (HSG) demonstrates the morphology and patency of both the

uterine canal and fallopian tubes (15,16). HSG is performed by injecting contrast

medium into the uterus and the fallopian tubes and following its flow using fluoroscopy.

Uterine abnormalities are outlined by the contrast medium and fallopian tubal

obstruction is noted by the absence of free spill into the peritoneal cavity (13,17). In

addition to the diagnostic value, HSG may also be used for therapeutic purposes to

unblock the blocked fallopian tubes (18,19).

The size of the uterine cavity varies with parity. The endocervical canal is of cylindrical

shape with length of 3 to 4cm and width of 1 to 3cm (1). The uterine cavity is sharply

defined by HSG having a triangular shape with mild concavity at the fundus. The

normal fallopian tube has a length between 10 to 12 cm extending from cornua of the

uterus. Its lumen is threadlike with width of 1 to 2mm until reaches ampulla where it

expands to 5 and up to 10mm with visible rugal folds.

Although HSG has a lot of advantages as outlined above, but there are some

disadvantages accompanying it. These are the possibility of allergic reaction to iodine,

pelvic infection, bleeding spots, endometriosis secondary to carriage of endometrial

tissue onto extra uterine sites and tubal rupture due to contrast material given under

pressure in patient with hydrosalpinx.

Other techniques for assessing structural causes of female infertility such as ultrasound,

sonohysterography (Hycospy), laparoscopy, magnetic resonance imaging (MRI) and

hysteroscopy are increasingly used elsewhere. HSG is not reliable test for evaluation of

extrinsic tubal pathology such as peritubal adhesions compared to other techniques

3

(20,21,22). However it has the advantage over other techniques by giving a clear tubal

resolution and definition (2,15).

In hysteroscopic procedure the scope is used to visualize the inside of the uterus

including the openings of fallopian tubes and can be used for treatment of intrauterine

pathology. However the procedure may complicate rarely with perforation of the uterus,

infection and reaction to anaesthetic agents.

Laparoscopy examination provides accurate information about extrinsic tubal pathology

but is poor in diagnosing intrinsic tubal pathology. Laparoscopy is performed under

general anaesthesia during the follicular phase of the menstrual cycle. After making

pneumoperitoneum, a thorough inspection of pelvis and pelvic organs is performed. This

is followed by testing the patency of fallopian tubes using methylene blue. A dilute

solution of methylene blue is injected through the cervix via a cannula. The evaluation of

adhesions, structural abnormalities of the uterus, endometriosis and fallopian tubes

occlusion are sought for.

Laparoscopy also has the advantage of allowing treatment of abdominal pathology such

as endometriosis and peritubular adhesions. Moreover, both laparoscopy and

hysteroscopy procedures are invasive with related risk of surgical complications, high

cost as well as high expertise. They are not able to give detailed information on the

uterine, making them disadvantageous over HSG. A study done in India revealed that

Hysterosalpingography and Laparoscopy are complimentary rather than competitive

procedures (23). Both hysteroscopy and laparoscopy should therefore be reserved for

confirmation and treatment of the intrauterine and fallopian tubes abnormalities (24,25).

4

Ultrasound has a great role in diagnostic as well as therapeutic management of infertility.

It can confirm the normal anatomy of the pelvis, assessing ovarian morphology and look

for uterotubal and pelvic pathology such as fibroids, hydrosalpinx and endometriosis.

Ultrasound is also used in monitoring menstrual cycle so that ovulation can be confirmed

in both natural cycles and due to induction agent like clomifene. However ultrasound is

poor in confirming the patency of fallopian tubes (26,27).

In experienced hands sonohysterography is safe, well tolerated and easy to assess

intrauterine structures more superior than HSG (28,29). In this procedure the cervix is

inspected through vaginal speculum and cleansed with antiseptic solution. A

polyethylene cannula is introduced and the speculum removed. Then a sterile sheathed

vaginal ultrasound probe is introduced. Lastly, an infusion of normal saline is

commenced gradually with a slow and sustained flow while scanning the endometrial

cavity and myometrium. Several studies showed that sonohysterography (Hycospy) is

similar to HSG as regards to the appearance of endometrial cavity but is inferior to it for

evaluation of tubal factor (30-34).

Magnetic resonance imaging (MRI) is the study of choice in infertile women with

suspected uterine anomalies because of its high accuracy and detailed elaboration of

uterovaginal anatomy. It is superior in diagnosing uterine anomalies, but is poor to

diagnose intrauterine adhesions and peritubal adhesion as compared to HSG (35).

1.3 HSG Findings

The normal HSG findings in infertile women was found to be low, 16.6% in Uganda

and 18.2% in South Africa(2,6), whilst in UK and Nigeria studies showed high

proportion of infertile women with abnormality, 51.5% and 60% respectively (3,15).

5

Almost one quarter of women with congenital or acquired structural uterine

abnormalities experience difficult in conception, accounting for up to 10% of infertility

cases (2). HSG has been found to be an invaluable procedure for the assessment of intra-

uterine lesions(18,36,37).The uterine abnormalities using HSG were present in 25% of

South African black patients with half of them having fibroids and only 2.5% of cases

had congenital abnormalities(6). However in a study conducted in UK only 15.2% of

cases had uterine abnormalities, in which 5.8% presented with congenital abnormalities

and 5.5% of the cases presented with fibroids with rest being polyps, Asherman

syndrome and post-caesarean scar(15). The congenital uterine abnormalities among

Nepalese women with primary infertility are 3.2% whilst those with secondary infertility

are 2% (47).

HSG is widely used as a first line approach to assess the patency of fallopian tubes in

routine fertility work-up (15,16).Tubal factor remain a cause of infertility which accounts

for 35% to 40% of cases of infertility(3,7,23). Previous studies revealed that tubal

pathology is significantly associated with secondary infertility(8) .In a study which was

done in South Africa among infertile black patients, 81.8% of cases had fallopian tube

abnormalities(6). In that study 5% of cases had peritoneal adhesions while the tubal

blockage was present in 27.4% of cases and the most common abnormality was the

terminal hydrosalpinx(6). Bilateral tubal occlusion was noted in 20% of infertile women

in a study done in Kenya. In several studies hydrosalpinx was the most common tubal

abnormality (3,6,15). Similarly, series done in Nigeria showed that hydrosalpinx was the

most common tubal abnormality which was present in 23.3% of patients. In this study

patients with bilateral tubal blockage were 7.5% while 13.3% of cases had unilateral

tubal blockage (3).

Tubal blockage was present as the most common tubal abnormality, 37.7% in a study

done in Birmingham, UK with hydrosalpinx accounting for 20.6% of cases(15).

6

In a study done in Turkey, 21% of infertile women had one sided tubal occlusion and

12% had bilateral tubal occlusion. Features for adnexal adhesion were seen among 12%

of infertile women in Turkey (9).

Therefore, assessment of the structural integrity of the reproductive tract is essential to

fertility evaluation and necessary for all female patients presenting with infertility. Thus

HSG still remains a more accurate and efficient method for the diagnosis of intrinsic

tubal and uterine pathology.

7

2.0 PROBLEM STATEMENT

Infertility is a global problem, but the highest prevalence is in low resources areas,

particularly Sub-Saharan Africa where infection-related tubal damage is the commonest

cause (38). The prevalence of uterotubal structural abnormalities by HSG ranges from

about half among women with infertility in Nigeria to three quarter in Uganda and South

Africa (2,3,6).

Currently in Tanzania little is known about the magnitude of the problem in terms of

common etiological factors; what is the most common cause of infertility, is it ovulatory

dysfunction, or is it structural abnormalities or is it hormonal infertility.

Observation of patients attending Radiology department at MNH reveals significant

number of women with infertility coming for evaluation of structural abnormalities.

In view of above arguments there is a need to conduct an investigation that is reliable and

which is readily available for screening possible structural abnormalities in reproductive

anatomy.

This can easily be done by hysterosalpingography (HSG) which is widely available in all

regions in Tanzania. It is affordable, readily available and yields reliable findings.

Therefore, this study looks into clinically reliability and usefulness of HSG in evaluation

of structural pathology in uterus, fallopian tubes and pelvis.

8

3.0 STUDY RATIONALE

The prevention of infertility in a population requires an active surveillance mechanism to

be in place. Previous studies done in other parts of Sub-Saharan Africa showed that the

major underlying cause for the high levels of infertility is the tubal blockage which is a

sequel of pelvic infection. These infections follow mismanaged deliveries, abortion and

sexually transmitted infections.

This calls for a study that is cheap, available and sensitive to document the pattern of

uterine and fallopian tubes diseases that are the culprit of infertility among women in our

setting.

In developing countries like Tanzania where resources are still limited, widely available

fluoroscopy units can be wisely used to investigate and even manage the women with

infertility.

Therefore, the results of this study will reveal the prevalence of uterotubal structural

abnormalities that will be used for comparison with other studies elsewhere and assist in

planning of future research areas on infertility.

Use of HSG investigation in infertile women may provide important information useful

to the Gynaecologist during treatment planning. It will also provide useful information on

pattern and proportion of uterine and tubal abnormalities necessary for formulating

various strategies for prevention of infertility, as almost all causes of tubal blockage are

preventable.

9

Therefore by knowing these underlying causes, various strategies can be put in place

through improving prevention, diagnosis and treatment of infertility at all levels of health

care delivery. Hence, this study is significant in the sense that the findings contained

herein will contribute to knowledge concerning the role of uterotubal structural

abnormalities as the cause of infertility in women.

10

4.0 OBJECTIVES

4.1 Broad Objectives

To describe imaging findings in infertile female patients who underwent

Hysterosalpingography investigation at Muhimbili National Hospital (MNH), Radiology

department, July to December, 2010.

4.2 Specific Objectives

1. To determine the proportion of women with congenital uterine anomalies.

2. To determine the proportion of women with tubal blockage.

3. To determine the pattern of uterotubal abnormalities in infertile female patients.

4. To determine association between the type of infertility and diagnosis of abnormal

HSG findings.

11

5.0 METHODOLOGY

5.1 Study Design and Period;

This was a descriptive cross sectional study conducted between July to December, 2010.

5.2 Study setting;

5.2.1 The study was conducted at Muhimbili National Hospital, Radiology department.

Patients were referred from gynaecology clinic of MNH by a gynaecologist. HSG

procedure was performed by an investigator supervised by a radiologist on duty. The

findings were interpreted by the investigator and discussed with the senior radiologist

before handled to patients.

5.2.2 Hysterosalpingography Procedure; There was no specific patient preparation

required and the examination was scheduled during days 7-12 of the menstrual cycle.

The endometrium is thin during this proliferative phase, a fact that facilitates image

interpretation and should also ensure that there is no pregnancy. The patient instructed

to abstain from sexual intercourse from the time menstrual bleeding ended until the

day of the study to avoid a potential pregnancy. The patient placed on the fluoroscopy

table in the lithotomy or modified lithotomy. The perineum cleaned with savlon and

draped with sterile towels. A speculum was inserted in the vagina and the cervix

localized and cleansed with savlon. Then a cannula positioned in the cervical canal. A

scout radiograph of the pelvis then taken with cannula in place. Water soluble contrast

(Ultravisit) about 10-30 ml slowly instilled with fluoroscopic images obtained

intermittently to evaluate the uterus and fallopian tubes. The first image obtained

during early filling of the uterus and used to evaluate any filling defects or contour

abnormality. The second image was taken with uterus fully distended, the shape of the

12

uterus is best evaluated at this stage. The third image was obtained to demonstrate and

evaluate the fallopian tubes and free intraperitoneal spillage of contrast material

5.3 Study Population; The study involved women who were evaluated at the Radiology

department due to infertility between July and December, 2010.

5.4 Exclusion criteria; The study did not involve women patients with acute infection of the

vagina or cervix and also women with active vaginal bleeding. Other groups of patients

that were also excluded from the study were those with sub fertility complaints lasting

less than a year.

5.5 Sample size Estimation; Considering the study power of 95%, a random likely error is

estimated to be 5%.The sample size of 113 patients were to be studied estimated basing

on the general population prevalence of 8.1% of infertile women in Tanzania(5). The

standard sample size estimation formula(Kish and Leslie) is N = z2p (1-p) ÷ E2 where

Z – is the point of normal distribution corresponding to the significant level of 1.96; p-

prevalence from the general population of infertile women which is 0.08; E – Maximum

likely error which is 0.05. Therefore the sample size is calculated as follows N=

(1.96)2*0.0.8(1-0.08) ÷ 0.052 =113

5.6 Sampling technique; a consecutive sampling method was used, due to limited time and

difficult in defining sampling frame as there is no specific clinic for infertility. Hence all

patients referred to the Radiology department for hysterosalpingography examination

were included after considering inclusion and exclusion criteria till the sample size

reached.

5.7 Data collection; Data collection in this study involved interviewing the patients to obtain

the demographic particulars. The special designed clinical surveillance forms (Appendix

I) used to collect both demographic and HSG findings. Data collections from each day

were done on the same day and then the obtained data were recorded in sheets and

13

transferred to the analysis program. To minimize the observer bias the report included the

documentation from the investigator and certification from a senior radiologist. The

findings were then communicated to the patients through the gynaecology clinic as they

continued to be followed up.

5.8 Data analysis;

The identification number was labelled in each of the filled clinical surveillance form and

screened before entering into the statistical package for social science (SPSS). Quantitative

data were then tabulated, analyzed and interpreted according to the result obtained. Then all

variables summarized and printed out for careful study and a cross tabulation done for defined

independent variables in order to obtain table of results. Data entry, filter and analysis was

done using SPSS version 15 analysis program. Chi- square statistical test was done to check

for statistical significance p<0.05.

5.9 Ethical consideration

Research protocol was submitted to the MUHAS Higher Degrees Research and Publications

Committee for review, approval and ethical clearance processing. Ethical clearance letter was

obtained before commencing the study. The aim of the study as well as potential risks and

benefits were clearly explained to all participants and a written informed consent in Swahili

language was signed by each participant (Appendix II). A participant had the right and

freedom to join or leave the study unconditionally. A patient who did not consent for the

study but entitled was attended as usual. Confidentiality was observed during performing the

HSG procedures as well as during conversation. A written report of findings was given to

patient and sent to gynaecologist.

14

6.0 RESULTS

6.1 Demographic and clinical data

One hundred and thirty (130) patients with infertility were interviewed and investigated.

The age ranged from 20 to 44 years showing normal distribution with mean age of 29.87

(Figure 1). The duration of infertility ranges from 1 to 17 years with a mean duration of

4.89 years as shown in table 1.

Table 1: Descriptive statistics

Minimum Maximum Mean S.d 95% CI p-value

Age (years) 20 44 29.89 4.97 29.01,30.37 0.00

Duration(years) 1 17 4.89 3.67 4.26,5.51 0.00

LMP(days) 7 12 9.97 1.67 9.68,10.26

Age45403530252015

Freq

uenc

y

12

10

8

6

4

2

0

Histogram

Mean =29.87�Std. Dev. =4.967�

N =130

Figure 1: Histogram showing age distribution of patient

15

Table 2 shows that more participants had secondary infertility 68 (52.3%). More patients

70(53.8%) aged 16-30 years . The young aged group 16-30 years had a high proportion of

primary infertile participants(67.7%) while more secondary infertile patients,58.8% were in

age 31-45 years which was statistically significant (p= 0.002).

Table 2: Age distribution by type of infertility

Type of infertility

Age groups Primary % Secondary % Total %

16-30 42 67.7 28 41.2 70 53.8

31-45 20 32.3 40 58.8 60 46.2

Total 62 47.7 68 52.3 130 100

Pearson Chi-square,x2=9.209, df=1, p-value=0.002

6.2 Hysterosalpingography findings

6.2.1 HSG findings by demographic characteristic and fertility status of women. Table 3 shows that patients who aged 31-45 years had more abnormal HSG findings (71.7%)

than those of aged 16-30 years. The difference seen is statistcally significant (p-value=0.012).

However patients with secondary infertility had slightly more abnormal HSG findings

(60.3%) than those with primary infertility (59.7%). This difference is not statistically

significant (p-value=0.943). More patients had duration of infertility of 1-5 years (63%) and

those with long duration (5-17 years) had more abnormal HSG findings (73%) compared to

those with short duration(52%). This difference is statistically significant(p-value=0.021).

16

Table 3 . HSG findings by demographic characteristic and fertility status(N=130)

HSG Findings Statistics Normal Abnormal p-value Age groups 16-30 35(50%) 35(50%) 0.012p 31-45 17(28.3%) 43(71.7%) Type of infertility Primary 25(40.3%) 37(59.7%) 0.943p Secondary 27(39.7%) 41(60.3%) Duration of infertility(years)

1-5 39(48%) 43(52%) 0.021p >5 13(27%) 35(73%) P= Pearson chi square 6.2.2 Pattern of uterine and fallopian tubes abnormalities

The study revealed that fallopian tubal blockage was the highest abnormality affecting

53(41%) infertile women followed by 25(19%) women with uterine abnormality, 23(18%)

women with pelvic adhesion and 17 (13%) women with hydrosalpinx as shown in figure 2.

0

10

20

30

40

50

Uterin

e ab

norm

ality

Tubal

block

age

Hydro

salpi

nx

Pelvic

adhe

sion

Pattern of uterotubal abnormalities

Pattern of uterotubalabnormalities

Figure 2. Distribution of uterotubal abnormalities

17

6.2.3 HSG uterine findings

Table 4 shows that uterine filling defect due to fibroids was the most common abnormality

seen accounting for 10% of all patients(figure 4), the irregular uterine cavity which may be

due to endometritis or synechiae was seen in 5.4% while patients with congenital abnormality

was 3.8% (figure 3).

Table 4: Summary of HSG uterine findings

Characteristics Frequency %

Unicornuate 2 1.5

Bicornuate 1 0.8

Arcuate 2 1.5

Irregular uterine cavity 7 5.4

Fibroids 13 10

Normal 105 80.8

Total 130 100

Figure 3: HSG images showing bicornuate uterus.

18

Figure 4: HSG showing filling defect(A) in early image and deformed uterus (B) in late

image due to fibroid

6.2.4 HSG fallopian tubes findings

Unilateral tubal blockage either the right or left tube, was the most tubal abnormality observed

in 28 patients (21.5%), bilateral tubal blockage was noted in 25 patients (19.2%). Unilateral

hydrosalpinx (figure 5) was noted in 11 patients (8.5%) while bilateral hydrosalpinx was seen

in 6 patients (4.6%). Tubal adhesions were found in both sides in 11 patients (8.5%) and

unilaterally in 12 patients (9.2%). This is shown in table 5

Table 5: Summary of HSG fallopian tubes findings (N=130)

Characteristics Frequency %

Bilateral blockage 25 19.2

Unilateral blockage 28 21.5

Bilateral hydrosalpinx 6 14.6

Unilateral hydrosalpinx 11 8.5

Bilateral adhesion 11 8.5

Unilateral adhesion 12 9.2

N 130

19

Figure 5. HSG Showing left hydrosalpinx and irregularity in lower uterine cavity

20

Figure 6. Normal HSG shows filling of uterus and both fallopian tubes in (a) and peritoneal

spillage in (b)

a

b

21

7.0 DISCUSSION

This cross-sectional study analysed the findings in HSG as observed in infertile women

attended Radiology department at MNH in Dar-es-Salaam. A consecutive sampling method

was used due to limited data collection time, accessibility to target group and shortage of

resources. The study was also for partial fulfilment of masters of medicine in Radiology.

The sample in this study may not be a true representation of Dar-es-Salaam women

inhabitants with infertility as it included only those patients who attended MNH radiology

department with infertility. However the sample size was reasonable enough and the age

distribution of patients followed a normal distribution curve that gives a confidence in the

results obtained. Despite these limitations, the findings discussed below may be useful in

planning a more large scale study in the topic of infertility and HSG in general.

Infertility in women is the main indication to undergo hysterosalpingography examination.

About 40-45% of infertility is attributed by female factor including cervical factors,

endometrial-uterine factors, ovarian factors and peritoneal factors. Male factors attribute for

about 25-40% while both male and female factors account for 10% and the remaining 10% is

due to unexplained factors. Therefore infertility workup is incomplete without an initial

hysterosalpingography examination that will depict abnormality in uterus and fallopian tubes.

In this study more patients had secondary infertility than those with primary infertility which

is similar to other previous studies (2,3,6,7,8). However this differs from other studies where

it was found that primary infertility is commoner (9,10). This higher rate of patients with

secondary infertility compared to the primary infertility can be used as a crude indicator of the

possible effects of pelvic inflammatory infections in our setting (3,41).

22

The participants included in this study were of mean age of 29.89 years which was similar to

the mean age of infertile women in Uganda and Nigeria (2,3) and lower than those in Turkey

(9) and higher than those in Iran (10).

The mean duration of infertility was 4.26 years which is similar to other studies done in

Nigeria and Turkey (3,9). The mean duration of infertility is reported low in other previous

studies conducted in Nepal and India (14,37). Most of patients in this study had 1- 5 years of

infertility but majority of patients who had long duration of infertility, between 6-17 years,

showed significant maximum number of abnormalities (73%). This long duration could be

due to hesitancy of patients in seeking early advice fearing for marital disharmony. Another

reason that could contribute to this long duration of infertility may be due to unawareness of

the importance of early treatment among the infertile couple. The presence of enormous local

tradition healing practices as well as other alternative medicine practices could be an

important contributory factor for the delay in coming earlier to health facilities.

In the present study of 130 patients, 52 cases (40%) had normal HSG findings. 78 patients had

abnormal findings accounted for about 60% of total cases. The reason behind this could be

due to the fact that MNH being the tertiary level hospital receiving referrals from periphery

health facilities where initial evaluation of infertility causes has been done. Also most of these

patients have already seen and evaluated in MNH Gynaecology clinic for other causes of

infertility and found normal, hence more likely to have structural abnormalities.

Hysteroscopy is the best technique for the diagnosis of uterine endometrial pathology because

small submucosa myoma and polyps can be missed by hysterosalpingography. However no

case of abnormal HSG findings will have normal finding in hysteroscopy, meaning false

positive rate of HSG is close to zero. In comparison to hysteroscopy the accuracy rate of

HSG in diagnosing endometrial pathology ranges from 75% to 90% (4,34). Therefore in this

23

study there is possibility that few patients who had normal finding could have small

submucosa myoma and polyps which were not picked up by HSG.

Congenital abnormalities of the uterine shape are the result of abnormal fusion of Mullerian

ducts during the early weeks of gestation. The most common anomaly is the arcuate uterus

which has no impact on fertility. In this study it was demonstrated that arcuate, unicornuate

and bicornuate uteri were common congenital abnormalities of the uterus encountered 3.8%.

This is also quoted in previous studies (1,6,36,42). The common uterine pathology in this

study was the presence of fibroids (10%). Fibroids which project in the uterine cavity such as

those of submucosa will cause the actual filling defects which can be detected by the HSG.

Uterine cavity may be distorted in its shape when the uterus has a large myoma. So HSG is of

great value in evaluation of uterine cavity and fallopian tubes patency when planning for the

myomectomy.

Irregular uterine cavity which is a sign of infection was present in 5.4%. This may be due to

endometritis or synechiae following PID, post abortal or post partum infections (3,41). This

distortion of uterine cavity due to both congenital and acquired causes result in infertility due

to failure of embryo implantation or spontaneous abortion. Preterm labour, malposition of the

foetus and obstructed labour may be another sequel of the uterine cavity distortion.

Previous studies that compared HSG and laparoscopy showed that ,HSG has a high specificity

of 80% and low sensitivity of 65% for detecting tubal patency (6,9,15,21). Another study

showed that HSG is as accurate as laparoscopy in the diagnosis of tubal patency or blockage

(22). Therefore due to its high specificity, making HSG a useful test for ruling out tubal

obstruction. When patency is demonstrated in HSG, there is little chance that the tube to be

actually occluded.

24

Most patients in this study (41%) were found to have tubal blockage which is similar to what

was reported in Uganda, Nigeria and Pakistan (2,8,36). Other previous studies reported that

tubal blockage accounted for less than 41% (3,10,14,15), whilst in South Africa reported to be

higher accounting for more than 67.2% (6,7). The main reason for this high proportion of

patients with tubal blockage is more likely due to high prevalence of pelvic inflammatory

diseases among women in our environment (2,6). Majority of patients with secondary

infertility showed higher proportion of tubal blockage which is similar with some previous

studies (8,24). In a study done in Nepal revealed the same incidence of tubal blockage in both

primary and secondary infertility (47).

However in HSG a common pitfall is non opacification of fallopian tube due to spasm.

Though antispasmodic was not used routinely in this study, its use would not have reduced

the number of patients with tubal blockage significantly as very few patients show tubal

spasm. Another false negative result occurs when there is inadequate wedging of cervical

cannula allowing leakage of contrast material into the vagina, thus interfering with generation

of sufficient intracavitary pressure and leading to misdiagnosis of tubal blockage. During this

study senior radiologist was called upon whenever the procedure was difficult and suspicious

of tubal spasm. Contrast intravasation into uterine and ovarian veins can sometimes be

mistaken for tubal filling, therefore is important to remember the anatomical locations of

these vessels. In order to minimise the chance for contrast intravasation patients were

scheduled during menstrual proliferative phase between 7th to 12th day when the endometrium

is thin and not fragile.

In our study majority of patients with tubal blockage were of older age (31-45years) in both

types of infertility (53.3%). This same result was reported in the literature previously in

Nigeria and India (8,24). This could be due to the increased risk of acquiring pelvic infection

with age.

25

Hydrosalpinx which is not detected by pelvic examination can be diagnosed by HSG.

Hydrosalpinx is seen as a dilated convoluted tubular structure on HSG which gradually

increase in size due to distal tubal occlusion. It is a result of fallopian tubes inflammation

following infections like gonococcal, chlamydial or tuberculosis of the genital tract. The

fimbrial ends are eventually occluded due to adhesions leading to collection of the secretions

in the lumen with gradual distension of the fallopian tube.

In this study 17(13%) patients had hydrosalpinx either unilateral or bilateral which was

similar with that reported in previous study done in Uganda (2) and higher than those reported

in Iran and Kathmandu (10,14).

Peritubal adhesions occur secondary to previous surgery or inflammation similar to the cause

of tubal occlusion. Adhesions around the fallopian tube results in loculation of contrast

material that has spilled from the fallopian tubes. Patients with features of pelvic adhesions

accounted for 18% of all infertile patients in this study. A study conducted previously in

Uganda showed that the peritubular adhesion was high (28%) while that done in Pakistan was

low, 7% of all patients (2,36)

This high incidence of tubal related pathology may be due to the following reasons. The first

is PID which is reported to be the most common gynaecological disease affecting many

African women (2,6,43). The second reason is that, in this group may be non compliance to

PID treatment that may lead to sub acute or chronic PID with deleterious effects on the

fallopian tubes. This indicates that pelvic inflammatory disease (PID) is still common in our

set up and makes it a common cause of infertility.

26

In this study it was observed that equal proportion of participants in both primary and

secondary infertility had utero-fallopian tubes pathology in general. This is different from

previous studies which showed the secondary infertile patients to have higher proportion of

pathology than primary infertile patients (8,24). A larger sample size would have been

appropriate in this study in order to get similar results, because there is slightly higher

proportion of patients with abnormality in secondary compared to primary infertility (60.3%

vs 59.7%). And also most pathologies are also higher among secondary than primary

infertility when considering individual uterotubal abnormalities.

27

8.0 STUDY LIMITATION

Limitation in design of study was the greatest set back in this study. This was due to time

limitations that could not be avoided, hence a non random sampling method was used instead

of random sampling method. Also there was no special clinic for infertility at MNH rather

patients were seen in usual general gynaecology clinic made it difficult to define sampling

frame, hence a consecutive sampling method could not be avoided.

However consecutive sampling method results in more representative sample in comparison

to convenient sampling method.

9.0 CONCLUSION

Generally, high proportion of patients in this study showed presence of uterine and fallopian

tube pathology. Fallopian tubal blockage was the highest observed tubal structural

abnormality while fibroid was the highest uterine pathology. There was no significant

difference in the presence of pathology between patients with primary and secondary

infertility. Older age above 30 years was more associated with presence of structural

abnormality in both uterus and fallopian tubes.

28

10.0 RECOMMENDATIONS

More than half of patients investigated in this study had uterotubal abnormalities, thus making

HSG being effective method for initial work-up of infertile women. Equipment and

consumables associated with this investigation should be readily available.

Further studies are needed to investigate the etiologies of these abnormalities at the earliest ,

this could be a measure to bring down the occurrence of such conditions.

There is a need of more studies on HSG findings using much bigger sample sizes to be

conducted in Tanzania.

There is a need to raise public awareness on causes and risk habits leading to infertility.

A large combined study with gynaecologist to find causes of infertility among the remaining

40% infertile women with normal HSG findings is recommended.

29

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Livingstone.Textbook of Radiology and Imaging 7th Edition.Vol.2 pg.1084-1090 ,

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15) Rajah R, McHuggo JM, Obhrai M. The role of hysterosalpiongography in modern

gynaecological practice .The British Journal of Radiology,1992;65:849-851

16) Perquin PAM, Dorr PJ, de Craen AJM, Helmerhost FM . Routine use of

hysterosalpingography prior to laparascopy in the fertility work up: multicenter

randomized controlled trial. Human Reprod 2006;21:1227-31

17) Chapman S, Nakienly R. Reproductive system. In: A guide to Radiological procedures.

Saunders publishers. London. 4th Edition, 2001, pg. 175-178.

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18) Salle B, Sergeant P, Gaucherand P, IGwimont I, de Saint Hillaire P, Rudigoz RC.

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with lipiodol ultra fluid. Acta Radiologica,1987 vol.28, No.3, pg.319-322

20) Sakar MN, Gul T, Atay AE, Celik Y. Comparison of hysterosalpingography and

laparascopy in the evaluation of infertile women. Saudi Med J 2008 Sep:29(9):1315-1318

21) Swart P, Mol BW, Van der Veen F, van Beurden M, Redekup WK, Bossuvt PM. The

accuracy of hysterosalpingography in the diagnosis of tubal pathology: a meta analysis .

Fertil Steril .1995 Sep:64(3):486-491

22) Fayez JA, Mutie G, Schneider PJ. The diagnostic value of hysterosalpingography and

laparascopy in infertility investigation . Int J Fertil 1988 Mar-Apr:33(2):98-101

23) Kanal P, Sharma S. Study of primary infertility in females by diagnostic laparascopy.

Internet Journal Of Medical Update,vol.1 No.2, July-Dec,2006

24) Fayez JA, Mutie G, Schneider PJ. The diagnostic value of hysterosalpingography and

hysteroscopy in infertility investigation. AM Journal Of Obstetric and Gynecology

,1987,March; 156(3): 558-560

25) Boudhraa K, Jellouli MA, Kassaoui O, Ben AN, et al. Role of the hysteroscopy and

laparascopy in management of female infertility. Tunis Medical Journal,2009 Jan:

87(1):55-60

26) Ragni G, Diaferia D, Vegetti W, Colombo M, Arnold M, Crosignani PG. Effectiveness

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27) Kaspa T, Gal M, Hartman M, Hartman J, Hartman A. A prospective evaluation of

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29) Salehpour S, Taheripanah R, Soltan L .An assessment of sonohysterography as a

diagnostic tool for uterine cavity defect and tubal patency. Journal of Reproduction and

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31) Strandell A, Bourne T, Bergh C, Grandberg S, Asztey M, Thorburn J. The assessment of

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patients. Ultrasound Obstet Gynecol. 1999 Sept:14(3):200-204

32) Oguntoyibnbo AE, Amok AOD, Komolafe OF. Sonographic assessment of fallopian tube

patency in the investigation of female infertility in Ilorin ,Nigeria. African Journal of

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33) Darwish AM, Youseff AA. Screening sonohysterography in infertility. Gynecol Obstet

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34) Bonilla-Mosoles F, Simon C, Serra V, Sampaio M, Pellicer A. An assessment of

hysterosalpingosonography(HSSG) as a diagnostic tool for uterine cavity defects and

tubal patency. J Clin Ultrasound 1992,Mar-Apr:20(3):175-181

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35) Malek KA, Hassan M, Soliman A, El-sawah H, Azab AO. A prospective comparative

study to assess the accuracy of MRI versus HSG in tubouterine causes of infertility.

Middle East Fertility Society Journal,vol.10,No.3,2005. 250-257

36) Naula U. Hysterosalpingography .Professional Med J, Dec 2005;12(4):386-391

37) Kumar S, Neelangi G. Assessment of uterine factor in infertile women :

Hysterosalpingography vs Hysteroscopy. MJAFI,2004,Vol.60 No.1: 39-41

38) Sharma S, Mittal S, Aggarwal P. Management of infertility in low resource countries. B

JOG,2009 Oct:116(1):77-83

39) Tvarijonavicene E, Nadisauskiane RJ. The value of hysterosalpingography in the

diagnosis of tubal pathology among infertile patients .

Medicina(Kaunas).2008:44(6):439-448

40) Mencaglia L, Colafranceschi M, Gordon AG, Lindemann H, et al . Is hysteroscopy of

value in the investigation of female infertility? Acta Eur Fertil 1988 Jul Aug:19(4):239-

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41) Besley .WHO Report: The epidemiology of infertility .A review with particular reference

in Subsaharan Africa. Bull WHO 1976;54:319-345

42) Shrivastava VR ,Rijal B, Shrestha A, Shrestha HK,Tuladhar AS. Detection of tubal

abnormalities by hysterosalpingography in Nepalese sub fertile women .Nepal Med Coll

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43) Favot I, Ngalula J, Mgalla Z , Klokke AH, et al. HIV infection and sexual behaviour

among women with infertility in Tanzania: A Hospital-Based study. International Journal

of Epidemiology 1997;26:2:414-419.

34

APPENDEX:I. DATA COLLECTION SHEET Part I. Demographic data

AGE Last

Menstrual

Period(LMP)

Type of

infertility

Duration of infertility

Part II. Clinical data

1. What are HSG findings?

a) Normal

b) Abnormal

2. Uterine abnormalities noted in 1 b) above

a) Yes

b)No

3. If yes in 2 above, which type

a) Unicornuate uterus

b) Bicornuate uterus

c) Septate

d) Irregular uterine cavity

e) Filling defects/fibroids

4. Fallopian tubes abnormalities noted in 1b?

a) Yes

b) No

5. I f the answer is Yes in 4 above, which type?

a) Right unilateral blockage

b) Left unilateral blockage

c) Bilateral blockage

35

6. Are there extrauterine abnormalities noted?

a) Yes

b) No

7. If the answer is Yes in 6 above, which type?

a) Adhesion

b) Mass

c) Other ,mention…………………..

36

APPENDEX: II. Consent: English version Informed Consent Form

Greetings!

I am Dr .Ramadhan Bihindi Kabala, a postgraduate student at Muhimbili University of

Health and Allied Sciences (MUHAS), investigating on the structural abnormalities of

the uterus an fallopian tubes as the causes of infertility among the patients who attend the

Gynecology clinic at Muhimbili National Hospital(MNH) using

Hysterosalpingography(HSG) investigation.

The main objectives of this study is to assess the usefulness and ability of the HSG

investigation to detect the abnormalities that cause the failure to conceive the pregnancy

which will help the Gynaecologist in treatment plan of the patient.

I f you agree to participate in this study ,you will be asked some questions and being

investigated for the patency of your fallopian tubes and uterus using HSG by introducing

the contrast media through the vagina and then x-ray images will be taken for

interpretation.

The HSG results and all information collected will be entered in the computer without

your name, but just using the identification number. We expect no harm to happen to you

during the course of this study but you will experience some pain during the procedure

and bleeding spots after the procedure. The study participation is completely voluntary

and refusal to participate or withdrawal will not involve penalty or loss of any benefits to

which you are entitled. You will be treated as per usual Hospital protocol for all patients

with infertility.

It is our expectation that information that will be gained from this study will be of

benefit for many infertile couples and the community at large..

In case you will have any other questions regarding this study, please feel free to contact

the investigator, Dr. Ramadhan Bihindi Kabala ,P.o.Box 65001, MUHAS, Dar es slaam.

Mobile phone ; 0713 682 405

If you have any questions concerning your rights as a participant, you may contact Prof.

E.F. Lyamuya, Chairman of the college research and publication committee, P.O. Box

37

65001, Dar es Salaam. Telephone: 2150302/6. Do you agree to participate? (Tick the

response) ...........YES ……….NO.

I, ………………………………………………………………………..have read the

consent form and my questions have been answered and I agree to participate in this

study.

Signature of Participant…………………………………………………………..

Signature of Investigator………………………………………………………….

Date of signed consent…………………………………………………………….

38

APPENDEX: III. Consent: Swahili version FOMU YA RIDHAA YA KUSHIRIKI UTAFITI

Salaam!

Ruhusa ya Kushiriki Utafiti Kuhusu “ uwezo wa kipimo cha HSG kuonyesha

magonjwa yaletayo ugumba kwa wanawake katika chumba cha uzazi na mirija ya

kupitisha mbegu”

Mimi naitwa Dr. Ramadhan Bihindi Kabala, ni mwanafunzi wa udhamili chuo kikuu cha

tiba Muhimbili. Ninachunguza sababu zinazosababisha ugumba kwa kutumia kipimo

kinaitwa HSG kwa wagonjwa wenye matatizo ya kupata mimba wanaotibiwa katika

kliniki ya magonjwa ya wanawake ya hospitali ya taifa Muhimbili(MNH). Dhumuni la

utafiti huu ni kuonyesha uwezo wa kipimo cha HSG kuonyesha magonjwa mbalimbali

katika chumba cha uzazi na mirija ya kupitisha mbegu za uzazi ambayo yanasababisha

tatizo hili la ugumba na ili matokeo yake yaweze kutumika kumuongoza Mganga katika

matibabu ya mgonjwa mbeleni.

Kama unakubali kushiriki kwenye utafiti huu, utaulizwa maswali, utapimwa chumba cha

uzazi na mirija ya kupitisha mbegu za uzazi kwa kuingiza dawa ukeni na kasha kupiga

picha kwa kutumia mionzi ya inayoitwa x-rays. Majibu ya picha zako yataingizwa

kwenye kompyuta na nambari ya utambulisho; jina lako halitatumika kwenye maelezo ya

utafiti. Tunategemea kwamba hakuna madhara yoyote makubwa yatokanayo na utafiti

huu, zaidi ya kusikia maumivu kiasi wakati wa kufanya kipimo na matone kidogo ya

damu baada ya kumaliza kipimo. Kipimo hiki hakina athari yoyote kwa afya yako

Kushiriki kwenye utafiti huu ni kwa hiari na kutokubali kushiriki au ukijitoa

hautaadhibiwa au kupoteza haki yako ya matibabu. Utatibiwa na kuendelea kufuatiliwa

kama taratibu za hospitali zinavyoelekeza kwa mtu mwenye matatizo ya kupata uzazi.

Tunatumaini kwamba taarifa zitakazopatikana zitawanufaisha wengine pia. Kama una

maswali au maelezo kuhusu utafiti huu, uwe tayari kuwasiliana na mtafiti, Dr. Ramadhan

Bihindi Kabala, MUHAS, P.O. Box 65216, Dar es Salaam. 0713 682 405.

39

Kama una maswali kuhusu haki yako kama mshiriki wasiliana na Prof. E. Lyamuya,

Mwenyekiti wa kamati ya utafiti, P.O. Box 65001, DSM. Simu 2150302/6. Je,

umekubali kushiriki? ........NDIYO, .......HAPANA

Mimi………………………………………………………..nimesoma maelezo na

maswali yangu yamejibiwa na nimekubali kushiriki kwenye utafiti huu.

Sahihi ya Mshiriki………………………………………………………………